A Placebo-Controlled Study of the Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 311
- Primary Endpoint
- Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
Overview
Brief Summary
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis of asthma at least 2 years prior to the Screening Visit.
- •Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months.
- •For participants 6 to 17 years of age, exacerbations for the purpose of the inclusion criteria, will be defined as:
- •An increase of four or more puffs of a short-acting beta-agonist (SABA) per day for at least 3 consecutive days, or
- •An increase of two or more nebulizations of a SABA per day for at least 3 consecutive days, or
- •Documentation of morning (AM) peak flow drops \>20% per day for at least 2 consecutive days, or
- •Documentation of AM peak flow drops of ≥50% for at least 1 day.
- •Must have been on a stable dose of any asthma medication (including immunotherapy) for at least 1 month prior to the Screening Visit.
- •Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when all prohibited medications have been withheld for the specified interval.
- •If a reversibility test has not been performed within the previous 24 months, a participant, ≥17 years of age, must demonstrate an increase in absolute FEV1 of ≥12%, with an absolute volume increase of at least 200 mL. A participant \<17 years of age, must demonstrate an increase in absolute FEV1 ≥12%.
Exclusion Criteria
- •Had an upper or lower respiratory illness or exhibits signs and/or symptoms of a respiratory illness in the 4 weeks prior to the Screening Visit.
- •Received any treatment more recently than the indicated washout period prior to Screening or who must continue to receive treatment that is prohibited.
- •Smoker or ex-smoker and has smoked within the previous 5 years of Screening or has had a cumulative smoking history \>10 pack years.
- •Allergy/sensitivity to the study drug or its excipients.
- •Female who is breast-feeding, pregnant, or intends to become pregnant.
- •Used any investigational drugs within 30 days of Screening.
- •Participating in any other clinical study.
- •Part of the staff personnel directly involved with this study.
- •Family member of the investigational study staff.
Arms & Interventions
Pleconaril
Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
Intervention: Pleconaril (Drug)
Placebo
Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
Intervention: Placebo to Pleconaril (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
Time Frame: From time of exposure to index case to end of Follow-up Period (21 days)
Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Percentage of Participants With Rhinovirus PCR-Positive Colds
Time Frame: From time of exposure to index case to end of Follow-up Period (21 days)
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Secondary Outcomes
- LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Total Cold Symptom Score(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Total Asthma Symptom Score(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage(Baseline through the Final Visit (Day 21))
- LS Mean Change From Baseline in Asthma-Related Sleep Interference(Baseline through the Final Visit (Day 21))